Efficacy and safety of kaolin-based hemostatic pad vs. standard mechanical compression following transradial and transulnar access for elective coronary angiography and PCI: RAUL trial substudy

Lewandowski Pawel, Gralak-Lachowska Dagmara, Maciejewski Pawel, Ramotowski Bogumil, Budaj Andrzej, Stec Sebastian

Heart Vessels 2020 Apr;35(4):502-508

Abstract

Hemostatic devices used in the transradial approach (TRA) and transulnar approach (TUA) are limited. This study compared the efficacy and safety of hemostasis using the QuikClot Radial hemostatic pad (QC) vs. standard mechanical compression (SC) after coronary angiography (CAG). This prospective single-center randomized trial included CAG patients. The primary and secondary endpoints were efficacy (successful hemostasis) and safety (total artery occlusion [TAO], pseudoaneurysm, hematoma), respectively. A visual analog scale (VAS) evaluated patient pain during compression. In 2013-2017, 200 patients were randomized 2 × 2 into the: (1) TRA and TUA groups and (2) QC and SC groups. Successful hemostasis was achieved in 92 (92%) patients in the QC group and 100 (100%) patients in the SC group (p < 0.006). The TRA SC subgroup showed significantly better results than the TRA QC subgroup (100% vs. 90.0%; p< 0.03). Similar results were obtained in the TUA QC and TUA SC subgroups (95% vs. 100%; p= 0.5). The secondary endpoint was achieved in the QC and SC groups (8% vs. 9%; p = 0.8). Patients reported significantly less pain during QC application than during SC (VAS: 2.6 ± 2.6 vs. 3.4 ± 2.9; p < 0.03). In patients undergoing CAG with TRA or TUA, QC was associated with lower efficacy, less discomfort, and similar safety compared to SC.